Nirsevimab

Nirsevimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetF protein of RSV
Clinical data
Trade namesBeyfortus
Other names
  • MEDI8897
  • nirsevimab-alip
AHFS/Drugs.comMicromedex Detailed Consumer Information
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6494H10060N1708O2050S46
Molar mass146336.58 g·mol−1

Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus (RSV).[10][11] It is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor[6] that is designed to bind to the fusion protein on the surface of the RSV virus.[12][13]

The most common side effects are rash, fever and injection site reactions (such as redness, swelling and pain where the injection is given).[8][14][15]

It was developed by AstraZeneca and Sanofi.[10][11] Nirsevimab was approved for medical use in both the European Union[9][16] and the United Kingdom in November 2022,[5] in Canada in April 2023,[2][17] and in the United States in July 2023.[15]

  1. ^ a b "Beyfortus APMDS". Therapeutic Goods Administration (TGA). 8 December 2023. Archived from the original on 7 March 2024. Retrieved 7 March 2024.
  2. ^ a b "Beyfortus Product information". Health Canada. 22 October 2009. Archived from the original on 8 August 2023. Retrieved 7 August 2023.
  3. ^ "Summary Basis of Decision for Beyfortus". Health Canada. 7 June 2023. Archived from the original on 12 January 2024. Retrieved 20 August 2023.
  4. ^ "Details for: Beyfortus". Health Canada. 19 April 2023. Archived from the original on 3 March 2024. Retrieved 20 August 2023.
  5. ^ a b "Respiratory syncytial virus (RSV) immunisation programme: JCVI advice, 7 June 2023". Medicines and Healthcare products Regulatory Agency (MHRA). 22 June 2023. Archived from the original on 11 July 2023. Retrieved 7 August 2023.
  6. ^ a b "Beyfortus- nirsevimab injection". DailyMed. 17 July 2023. Archived from the original on 7 August 2023. Retrieved 6 August 2023.
  7. ^ "Press Release: U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus (nirsevimab-alip) to protect infants against RSV disease" (Press release). Sanofi - Aventis Groupe. 3 August 2023. Archived from the original on 8 August 2023. Retrieved 7 August 2023 – via GlobeNewswire News Room.
  8. ^ a b "Beyfortus EPAR". European Medicines Agency. 23 June 2023. Archived from the original on 1 August 2023. Retrieved 6 August 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ a b Cite error: The named reference EU Union Register was invoked but never defined (see the help page).
  10. ^ a b "Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial" (Press release). Sanofi. 26 April 2021. Archived from the original on 27 December 2021. Retrieved 27 December 2021.
  11. ^ a b "Nirsevimab MELODY Phase III trial met primary endpoint of reducing RSV lower respiratory tract infections in healthy infants" (Press release). AstraZeneca. 26 April 2021. Archived from the original on 26 December 2021. Retrieved 27 December 2021.
  12. ^ Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. (Nirsevimab Study Group) (July 2020). "Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants". The New England Journal of Medicine. 383 (5): 415–425. doi:10.1056/NEJMoa1913556. PMID 32726528. S2CID 220876651.
  13. ^ Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, et al. (March 2022). "Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants". The New England Journal of Medicine. 386 (9): 837–846. doi:10.1056/NEJMoa2110275. PMID 35235726. S2CID 247220023.
  14. ^ Cite error: The named reference EMA PR 20220916 was invoked but never defined (see the help page).
  15. ^ a b "FDA Approves New Drug to Prevent RSV in Babies and Toddlers" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on 19 July 2023. Retrieved 19 July 2023. This article incorporates text from this source, which is in the public domain.
  16. ^ Cite error: The named reference AstraZeneca PR 20221103 was invoked but never defined (see the help page).
  17. ^ "Health Canada approves new antibody drug to help prevent serious RSV in babies". CTVNews. 22 April 2023. Archived from the original on 24 April 2023. Retrieved 24 April 2023.
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